RECRUITING

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Conditions

Follicular Lymphoma (FL)relapsed or refractory follicular lymphoma r/r FL CAR-T tisagenlecleucel CTL019 phase III standard of care SOC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

Official Title

A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)

Quick Facts

Study Start:2023-10-02

Study Completion:2031-01-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05888493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years at the date of signing the informed consent form. 2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment). 3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent. 4. Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan. 5. ECOG performance status of 0, 1 or 2 at screening. 6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening. 7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available). 8. Must be eligible for treatment with the selected standard of care regimen.	1. Follicular lymphoma grade 3B or evidence of histologic transformation. 2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy. 3. Active CNS involvement by malignancy. 4. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C. 5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome). 6. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization. 7. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years at the date of signing the informed consent form.
2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
4. Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
5. ECOG performance status of 0, 1 or 2 at screening.
6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
8. Must be eligible for treatment with the selected standard of care regimen.

1. Follicular lymphoma grade 3B or evidence of histologic transformation.
2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
3. Active CNS involvement by malignancy.
4. Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
6. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
7. Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

TRIHEALTH Good Samarithan Hospital

Cincinnati, Ohio, 45220

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02

Study Completion Date2031-01-18

Study Record Updates

Study Start Date2023-10-02

Study Completion Date2031-01-18

Terms related to this study

Keywords Provided by Researchers

relapsed or refractory follicular lymphoma
r/r
FL
CAR-T
tisagenlecleucel
CTL019
phase III
standard of care
SOC

Additional Relevant MeSH Terms

Follicular Lymphoma (FL)